Let me be clear from the outset: this is not an argument against upgrading. Progress matters. New capabilities matter. Security improvements matter. What’s dangerous is not upgrading, but upgrading by ...

The Food and Drug Administration (FDA) has released guidance providing recommendations on what information should be included in a predetermined change control plan (PCCP) tailored to marketing ...

Most everyone knows networked multifunction printers can pose a dangerous weak link within an enterprise, but not everyone agrees on just how to secure them. Printer manufacturer Sharp upped the ante ...

I'm looking for some good change control software that's web based and utilizes SQL server. I used one a couple of years ago and can't recall the name. Google didn't turn up much that looked ...

At long last, the U.S. FDA finalized guidance on using predetermined change control plans in submissions for medical devices that include artificial intelligence. The guidance, “Marketing Submission ...

The U.S. FDA’s approach to predetermined change control plans (PCCP) for medical devices has been widely viewed through the lens of artificial intelligence software, but the potential scope of PCCP is ...